- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07575373
Feasibility of an Interdisciplinary Intervention to Improve Care Transitions for Hospitalized Patients With Substance Use Disorders (IntACT)
Evaluating the Feasibility of an Interdisciplinary Primary Care-based Intervention to Improve Transitions to Follow-Up Care for Hospitalized Patients With Substance Use Disorders: A Pilot Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This is a single site, unblinded, pilot randomized controlled trial that will enroll patients with SUD during an index hospitalization and randomize them to receive IntACT or usual care over an intervention period of 4 months. The study is designed to evaluate the feasibility and implementation of IntACT while simultaneously measuring preliminary effectiveness outcomes..
Intervention(s)
IntACT Intervention:
Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team providing: (1) in-hospital discharge planning support, (2) proactive post-discharge outreach and care coordination, (3) intensive care management and peer support, and (4) interim SUD and medical care coordination for up to 4 months post-randomization, with the goal of facilitating transition to longitudinal community-based care.
Upon randomization to the IntACT study arm, a member of the IntACT team (either peer navigator, clinician, or care manager) will deploy to the hospital to meet the participant, introduce their role, and exchange contact information. The IntACT team member will review the discharge plan with the participant and offer to facilitate any needed follow-up care at our partnering outpatient addiction medicine/primary care SPARC Clinic. They will outline a proposed post-discharge outreach plan to make sure that it is feasible and acceptable to the participant, with an expectation to perform the first outreach within 2 business days of discharge. The IntACT team member will also coordinate with the Addiction Consult Service and primary admitting hospital team as needed to address any perceived gaps in discharge care and to introduce themselves and their role, which is to provide added support after discharge and to facilitate linkage to follow-up care. A one-page contact sheet will be provided to the patient with a clinic cell phone number and contact information for both our peer support specialist and care manager during the initial visit. The IntACT team member will continue to communicate with the patient and the care team ad hoc during the remainder of the hospitalization to address any care coordination needs that arise. At our weekly IntACT clinical team meeting, the team will review the new participant's hospital course, medications, and discharge needs. Ensuing discussion will focus on how to best leverage the interdisciplinary IntACT team to improve post-discharge care. For example, the peer support specialist can provide outreach and linkage to daily free support meetings at Utah Support Advocates for Recovery Awareness (USARA) in addition to housing, legal, and vocational resources offered through USARA. The care manager can ensure adequate access to transportation, address food security and housing, and address perceived logistic barriers to engaging in care. The clinician can review medications such as antibiotics and medications for substance use disorder to ensure that there are no gaps in treatment after discharge. Within 2 business days of discharge, the IntACT team will outreach to the patient. This phone call will be focused on inquiring about unexpected symptoms and challenges faced after discharge, reviewing upcoming appointments and discharge medications, and assessing post-discharge substance use needs. The care manager will communicate with the rest of the IntACT team and leverage available community resources to address these needs. If the care manager is unable to reach the participant, they will keep trying together with the peer support specialist and clinician, at least 3 times per week for the first 3 weeks after discharge. This is in addition to any outreach from the research team. While follow up visit frequency will be individualized for each participant, most people will follow up every 1-2 weeks via appointments in SPARC or at another clinic/program of their choosing. For patients that follow up at SPARC, the IntACT team will be present at every clinic visit and available to coordinate on social and medical aspects of care. For patients that follow up elsewhere, care will be at weekly clinic team meetings and remote/asynchronous care will be provided to support a successful transition of care. The IntACT team will help to coordinate appointments with specialists if needed, liaising with their offices regarding scheduling and care plans. Telephone and/or EHR messaging outreach will occur at least weekly for the first month, then ad hoc for the remainder of the 4-month intervention period. These outreach calls may come from any member of the IntACT team. Care manager outreach will focus on assessing and addressing SUD-related and biopsychosocial aspects of follow-up care. Peer support specialist outreach will focus on community building and connection to SUD support resources. Clinician outreach will focus on medical and SUD treatment-related issues. In-person contact with the IntACT team will primarily be limited to regularly scheduled medical visits or outreach during any subsequent hospitalizations, with the exception of our peer support specialist who may accompany the participant to community meetings based on preference. There are no additional visits required of the patient to receive clinical care through IntACT.
Usual Care:
Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health, including inpatient addiction consult services when ordered, discharge planning by hospital medical and social work teams, and referrals/follow-up options based on insurance and patient preference. Usual Care participants will not receive the structured IntACT intervention components provided in the intervention arm, including proactive post-discharge outreach by the IntACT care manager/peer support specialist, intensive care management, dedicated peer navigation, scheduled interdisciplinary team review, or interim addiction/primary care transition services delivered by the IntACT team as part of the study. If a Usual Care participant independently establishes care with SPARC clinic or other services through standard referral pathways, this will be permitted and will be captured as part of outcome assessment.
After 4 months, the official intervention period will stop. Participants in both groups will still able to continue care with their current medical and SUD treatment teams, which may include members of IntACT.
Randomization: Randomization will be conducted at a single site using asymmetric allocation to favor the intervention arm. Participants will be randomized in a 3:2 ratio to either the IntACT intervention or Usual Care using random permuted blocks.
The randomization sequence and allocation procedures will be implemented via in-house, REDCap-based software application developed and maintained by the University of Utah. The randomization system will conceal the allocation sequence until the time of assignment. After baseline assessments and confirmation of eligibility, research staff will access the web-based system, which will assign the participant to IntACT or Usual Care according to the randomization algorithm
Blinding: Participants, clinicians, and the research team cannot be blinded due to the nature of the intervention.
Study duration: The IntACT intervention period is 4 months, followed by a close-out assessment by the study team at 6 months post-randomization. Total study duration is expected to be approximately 24 months including start-up, enrollment, and follow-up.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Michael Incze, MD
- Telefonní číslo: 801-581-7822
- E-mail: michael.incze@hsc.utah.edu
Studijní záloha kontaktů
- Jméno: Ulises Amaton, BA
- Telefonní číslo: 801-581-7822
- E-mail: ulises.amaton@hsc.utah.edu
Studijní místa
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- University of Utah Medical Center
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Kontakt:
- Michael Incze, MD
- Telefonní číslo: 801-581-7822
- E-mail: michael.incze@hsc.utah.edu
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged 18 years and older
- Hospitalized at University of Utah Medical Center (UUMC) for any medical reason, and
- Electronic Health Record (EHR) documented diagnosis of any SUD.
Exclusion Criteria:
- Currently incarcerated
- Tobacco use as only documented substance use disorder
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: IntACT Intervention
Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team.
|
Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team providing: (1) in-hospital discharge planning support, (2) proactive post-discharge outreach and care coordination, (3) intensive care management and peer support, and (4) interim SUD and medical care coordination for up to 4 months post-randomization, with the goal of facilitating transition to longitudinal community-based care.
|
|
Aktivní komparátor: Usual Care
Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health.
|
Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health, including inpatient addiction consult services when ordered, discharge planning by hospital medical and social work teams, and referrals/follow-up options based on insurance and patient preference.
Usual Care participants will not receive the structured IntACT intervention components provided in the intervention arm, including proactive post-discharge outreach by the IntACT care manager/peer support specialist, intensive care management, dedicated peer navigation, scheduled interdisciplinary team review, or interim addiction/primary care transition services delivered by the IntACT team as part of the study.
If a Usual Care participant independently establishes care with SPARC clinic or other services through standard referral pathways, this will be permitted and will be captured as part of outcome assessment.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Care Linkage
Časové okno: 14 Days
|
percentage of patients who attend any follow up visit within 14 days of hospital discharge.
Assessed using administrative records and patient self-report.
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14 Days
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Retention in Treatment
Časové okno: 6 Months
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Percentage of patients who have attended a medical or substance use treatment appointment within the past 30 days.
Assessed at 2 months, 4 months, and 6 months after randomization.
Assessed using clinic/administrative records and patient-self-report.
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6 Months
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Intervention Feasibility
Časové okno: Completed once within 2 weeks of exposure to the intervention
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Implementation-related outcomes will be collected from N=20 clinicians who are exposed to the IntACT intervention and IntACT team members, respectively.
Implementation outcomes include Feasibility, assessed via the 4-item Feasibility of Intervention measure (range 0-12, higher is more feasible)
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Completed once within 2 weeks of exposure to the intervention
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Intervention Acceptability
Časové okno: Completed once within 2 weeks of exposure to the intervention
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Implementation-related outcomes will be collected from N=20 clinicians who are exposed to the IntACT intervention and IntACT team members, respectively.
Implementation outcomes include Acceptability, assessed via the 4-item Acceptability of Intervention measure (range 0-12, higher is more acceptible)
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Completed once within 2 weeks of exposure to the intervention
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Intervention Appropriateness
Časové okno: Completed once within 2 weeks of exposure to the intervention
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Implementation-related outcomes will be collected from N=20 clinicians who are exposed to the IntACT intervention and IntACT team members, respectively.
Implementation outcomes include Appropriateness, assessed via the 4-item Intervention Appropriateness Measure (range 0-12, higher is more appropriate)
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Completed once within 2 weeks of exposure to the intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time to first follow-up visit, assessed using clinic/administrative records and participant self-report.
Časové okno: 6 Months
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Time until participant presents for first follow up visit.
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6 Months
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Emergency Department visits and hospitalizations
Časové okno: 6 Months
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Number of self-reported ED visits and re-hospitalizations
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6 Months
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Substance use
Časové okno: 6 Months
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Number of self-reported substance uses using Timeline Follow Back
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6 Months
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Participant quality of life
Časové okno: 6 months
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Quality of life outcomes measured by the 12-Item Short Form Health Survey (range 0-100, hgiher score means greater quality of life), a self-reported questionnaire assessing functional health and well-being,
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6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Michael Incze, MD, University of Utah
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB_00195935
- K23DA062174 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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